To assess the safety of treatment with pirfenidone (up to 3600 mg/d) in patients with pulmonary fibrosis/idiopathic pulmonary fibrosis (PF/IPF).
This study has been designed as a rollover study to collectively include safety data from various previous studies. In addition, InterMune has also initiated an Early Access Program to make pirfenidone available to a limited number of patients with idiopathic pulmonary fibrosis in the United States. This program is also being conducted under this protocol. Registration of patients with documented IPF has been closed as of October 2005.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
83
up to 3600 mg/day of pirfenidone given orally administered in divided doses three times daily with food, for the duration of the study
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were classified as severe (Grade 3) in following cases: marked limitation in activity; some assistance usually required; medical intervention/ therapy required, hospitalization possible. Treatment-emergent AEs were those occurring on or after the first dosing day and up to 28 days after discontinuation of study treatment, and those occurring before treatment that worsened after the first study dose. AE included serious as well as non-serious AEs.
Time frame: Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)
Percent Predicted Forced Vital Capacity (FVC)
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out from the lungs after full inspiration in the upright position, measured in liters. Predicted FVC is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (actual FVC value in liter)/(predicted FVC) \* 100%
Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480
Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)
DLco is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. Predicted DLco is based on a formula using sex, age and height of a person. Predicted DLco = \[Hbg-corrected DLco value (in milliliters per minute per millimeter mercury \[mL/min/mmHg\])/predicted DLco\] \* 100%
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Pomona, California, United States
Unnamed facility
San Jose, California, United States
Unnamed facility
New Haven, Connecticut, United States
Unnamed facility
Sarasota, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Kailua, Hawaii, United States
Unnamed facility
Lahaina, Hawaii, United States
Unnamed facility
Nampa, Idaho, United States
Unnamed facility
Elk Grove Village, Illinois, United States
...and 17 more locations
Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480
Resting Oxygen Saturation by Pulse Oximetry (SpO2)
SpO2 is the percentage of oxygen saturation in the blood. Oxygen level (oxygen saturation) of the blood was measured using pulse oximetry on room air.
Time frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480
Overall Survival
Survival was analyzed as time from first study dose to death (all-cause mortality) with surviving participants censored at their last available assessment.
Time frame: First dosing of study treatment until death (up to 604 weeks)